POS0853 EFFICACY OF FILGOTINIB (FIL) IN PATIENTS (PTS) WITH RHEUMATOID ARTHRITIS (RA): WEEK (W) 156 RESULTS FROM A LONG-TERM EXTENSION (LTE) STUDY
Authors: M. H. Buch, D. Aletaha, R. Caporali, B. Combe, H. Schulze-Koops, J. E. Gottenberg, Y. Tanaka, R. Blanco, T. Takeuchi, E. V. Ekoka Omoruyi, K. Van Beneden, V. Rajendran, C. Watson, F. De Leonardis, P. Emery
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate response (IR) or intolerance to ≥1 conventional synthetic disease-modifying antirheumatic drug (DMARD). FIL is a JAK1 preferential inhibitor available in two doses for the treatment of moderate to severe RA. <h3>Objectives</h3> To evaluate long-term efficacy of two doses of FIL in clinically relevant pt populations. <h3>Methods</h3> In this interim analysis, efficacy (non-responder imputation) of FIL 200 mg (FIL200) and 100 mg (FIL100) was assessed from LTE baseline (BL) to W156 in pts with an IR to methotrexate (MTX-IR) and biologics (bDMARD-IR), enrolled from FINCH 1 (NCT02889796) and 2 (NCT02873936) parent studies (PS), respectively, receiving ≥1 FIL dose in FINCH 4 (NCT03025308). <h3>Results</h3> Study design, BL characteristics and W48 outcomes for MTX-IR<sup>[1]</sup> and bDMARD-IR<sup>[2]</sup> pts were reported previously. For MTX-IR and bDMARD-IR pts who received FIL200 or FIL100 in the PS, W156 remission rates using Boolean 1.0 criteria were 20.5% and 15.8%, and 18.2% and 8.9%, respectively. Adopting the Boolean 2.0 criteria slightly increased remission rates for FIL200 and FIL100 at W156: +4.2% and +4.9% for MTX-IR pts, and +1.5% and +2.4% for bDMARD-IR pts, respectively. For pts rerandomized to FIL on entering the LTE, Boolean 2.0 criteria also increased remission rates vs Boolean 1.0. Both MTX-IR (<b>Figure 1</b>) and bDMARD-IR pts maintained long-term Boolean remission through W156 with FIL200 and FIL100, irrespective of prior FIL. Results for Disease Activity Score 28 with C-reactive protein (DAS28-CRP) &lt;2.6, Clinical Disease Activity Index (CDAI) ≤2.8, and Simplified Disease Activity Index (SDAI) ≤3.3, and mean change from PS BL in Health Assessment Questionnaire–Disability Index (HAQ-DI) and pain are shown (<b>Table 1</b>). Similar trends in efficacy were seen for LDA and ACR response criteria. <h3>Conclusion</h3> In FINCH 4, both FIL200 and FIL100 showed sustained efficacy up to W156 in clinically relevant pt populations. Boolean 2.0 criteria classified more pts in remission, in line with the range reported in the validation study.<sup>[3]</sup> <h3>References</h3> [1]Combe B, et al. Arthritis Rheumatol 2021;73(Suppl 9):POS1697. [2]Buch M, et al. Arthritis Rheumatol 2021;73(Suppl 9):POS1696. [3]Studenic P, et al. Arthritis Rheumatol 2023;82:74–80. <h3>Acknowledgements</h3> We thank the physicians and patients who participated in these studies. The FINCH studies were co-funded by Gilead Sciences Inc. (Foster City, CA, USA) and Galapagos NV (Mechelen, Belgium). Publication coordination was provided by Fabien Debailleul, PhD, of Galapagos NV. Medical writing support was provided by Stephanie Rippon, MBio (Aspire Scientific, Bollington, UK), and funded by Galapagos NV. <h3>Disclosure of Interests</h3> Maya H Buch Speakers bureau: AbbVie (paid to host institution), Consultant of: AbbVie, CESAS Medical, Galapagos, Gilead, and Pfizer (all paid to host institution), Grant/research support from: Gilead (paid to host institution), Daniel Aletaha Speakers bureau: AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi, Consultant of: AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi, Grant/research support from: AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi, Roberto Caporali Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Fresenius, Galapagos, Janssen, Lilly, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Fresenius, Galapagos, Lilly, Novartis, Pfizer, and UCB, Bernard Combe Speakers bureau: AbbVie, Celltrion, Galapagos, Janssen, Lilly, Pfizer, and Roche-Chugai, Consultant of: AbbVie, Galapagos, Gilead, Janssen, Lilly, Novartis, and Roche-Chugai, Hendrik Schulze-Koops Speakers bureau: AbbVie, Galapagos, Lilly, and Pfizer, Consultant of: AbbVie, Galapagos, Lilly, and Pfizer, Jacques-Eric Gottenberg Consultant of: AbbVie, BMS, Galapagos, Gilead, Lilly, MSD, Novartis, and Pfizer, Grant/research support from: BMS and Pfizer, Yoshiya Tanaka Speakers bureau: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, GSK, Mitsubishi-Tanabe, and Pfizer, Grant/research support from: AbbVie, Asahi-Kasei Pharma, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Takeda, Ricardo Blanco Speakers bureau: AbbVie, Amgen, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and Sanofi, Consultant of: AstraZeneca, Galapagos, Janssen, Novartis, and Pfizer, Grant/research support from: AbbVie and Roche, Tsutomu Takeuchi Speakers bureau: AbbVie GK, AYUMI, BMS, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Gilead Sciences, Inc., Janssen Pharm K.K., Mitsubishi-Tanabe, Pfizer Japan Inc., and Sanofi K.K., Consultant of: AbbVie GK, Astellas, Chugai, Eli Lilly Japan, Gilead Sciences, Inc., Janssen Pharm K.K., Mitsubishi-Tanabe, and Pfizer Japan Inc., Grant/research support from: AbbVie GK, Asahi-Kasei Pharma, Astellas, AYUMI, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Mitsubishi-Tanabe, Nippon Kayaku, and UCB Japan, Edmund V. Ekoka Omoruyi Shareholder of: UCB, Consultant of: Galapagos and Janssen, Katrien Van Beneden Shareholder of: Galapagos, Employee of: Galapagos, Vijay Rajendran Shareholder of: Galapagos, Employee of: Galapagos, Chris Watson Shareholder of: Galapagos, Employee of: Galapagos, Francesco De Leonardis Employee of: Galapagos, Paul Emery Speakers bureau: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Galapagos, Gilead, Lilly, Novartis, Pfizer, and Samsung, Consultant of: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Galapagos, Gilead, Lilly, Novartis, Pfizer, Roche, and Samsung, Grant/research support from: AbbVie, BMS, Lilly, Novartis, Pfizer, Roche, and Samsung.